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NCT05722301
Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial
Conditions: Arthroplasty, Replacement, Hip
Sex: Male
Ages: 50 Years – N/A
Healthy volunteers: 1
Phase: PHASE3
Sponsor: American Hip Institute
Location: United States
Summary
This randomized-controlled trial will study on the effect of testosterone therapy on patients undergoing total hip replacement.
Subjects will be male patients > 50 years with testosterone deficiency undergoing total hip replacement due to severe degenerative joint disease.
All participants will receive a total hip replacement and will be randomized to either testosterone therapy or placebo.
A total of 80 subjects will be recruited randomized into 2 groups of 40 subjects.
Testosterone therapy will be administered once to each patient at 2 weeks before surgery.
The long-term follow up will be the same as all patients with patient-reported outcomes after total hip replacement, VAS for pain and satisfaction at regular intervals.
Eligibility Criteria
Inclusion Criteria:Male patients50 years of age and olderIndividuals who have degenerative joint disease requiring total hip replacement after failure of conservative measures.Exclusion Criteria:History of prostate cancer less than 5 years ago or those men whom are not considered to be cancer freeHistory of breast cancer less than 5 years ago or those men whom are not considered to be cancer freeHistory of deep vein thrombosis (DVT)Presence of Factor V Leiden (as seen in labs)Presence of Protein S Deficiency (as seen in labs)History of atherosclerotic artery disease - by history having had a diagnosis made of CAD, MI, or strokeLiver disease (as viewed by liver function tests)Testosterone free level greater than 10pg/mLHematocrit >51%; PSA >= 3ng/mL.
Source: ClinicalTrials.gov (NCT05722301). StuddyBuddy aggregates publicly available trial information.
